Keystone Clinical Studies, LLC | Norristown, PA
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About
This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.
Full description
All administrations of study drug will be administered in the clinic; However, home administrations of study drug will be allowed per sponsor approval according to country and local guidelines during the COVID-19 pandemic and following its resolution, where permitted.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Core Study: Inclusion Criteria
Diagnosis: Mild Cognitive Impairment (MCI) due to Alzheimer's disease - intermediate likelihood:
Mild Alzheimer's disease dementia:
Key Inclusion Criteria that must be met by all participants:
Extension Phase: Inclusion Criteria:
Exclusion Criteria
Extension Phase: Exclusion Criteria
Participants who discontinued early from the Core Study
Participants who develop the following conditions from the time of Screening for the Core Study to the start of the Extension Phase
Primary purpose
Allocation
Interventional model
Masking
1,906 participants in 5 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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